Confidential ProjectConfidential
New IV Bag Filling Line
IV Bag Filling Line, Southwest USA
Abandoned cleanrooms brought back into service as two compliant IV-bag lines.

Project Brief

KeRi performed a feasibility study and design to upgrade an existing pharmaceutical manufacturing facility and add two additional IV bag formulation and filling lines in existing abandoned cleanrooms. The study established what the vacant suites and the utilities serving them could carry, where the new lines would fit, and what had to be replaced or added, and it set the basis of design carried into the construction documents.

The design included process flow diagrams, P&IDs, piping layouts, and sanitary piping specifications; HVAC sized to hold the required GMP classifications; plumbing for the process and critical utilities; electrical sized for current operations and future expansion; architecture coordinated with the modular cleanroom vendor for walls, ceilings, flooring, and HEPA filtration; and control-system functional specifications for WFI, clean steam, CIP, formulation, transfer, and filling, returning the abandoned cleanrooms to service as a compliant cGMP environment for reliable, scalable sterile production.

Sterile IV BagsTwo additional formulation and filling lines returned to service in cleanroom suites that had been abandoned.
Formulation and TransferWFI, clean steam, CIP, formulation, transfer, and filling, each carried by a control-system functional specification.

MEP Engineering Scope

IV Bag Filling Line interior

What We Engineered

Feasibility study, cleanroom upgrade, and fully coordinated MEP, structural, and architectural design:

  • Feasibility study of the abandoned cleanroom suites and the utilities serving them
  • Process flow diagrams, P&IDs, piping layouts, and sanitary piping specifications
  • HVAC systems sized to maintain required GMP classifications
  • Plumbing for process and critical utilities; electrical sized for current operations and future expansion
  • Architecture coordinated with a modular cleanroom vendor (walls, ceilings, flooring, HEPA filtration)
  • Control-system functional specifications for WFI, clean steam, CIP, formulation, transfer, and filling

The Challenge

Two additional IV bag formulation and filling lines had to fit into cleanrooms that had been abandoned, on utilities and infrastructure that first had to be proven capable of carrying them at scalable cGMP performance.

Our Solution

KeRi ran the feasibility study that set the basis of design, then delivered architecture, MEP, structural, and process design, including process flows and P&IDs, GMP-classified HVAC, process and critical utilities, expansion-ready electrical, modular cleanroom coordination, and control specs for WFI, clean steam, CIP, formulation, transfer, and filling.

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